Serious adverse events
|
Combination |
Aliskiren |
Enalapril |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
1466 / 2347 (62.46%) |
1504 / 2348 (64.05%) |
1501 / 2345 (64.01%) |
number of deaths (all causes)
|
349 |
403 |
392 |
number of deaths resulting from adverse events
|
0 |
0 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Acute myeloid leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of appendix
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
8 / 2348 (0.34%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adrenal adenoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
5 / 2348 (0.21%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign ear neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of skin
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of spinal cord
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign pancreatic neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign salivary gland neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
4 / 2348 (0.17%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder papilloma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm malignant
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer female
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
7 / 2345 (0.30%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carcinoma in situ of penis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carcinoma in situ of skin
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac valve fibroelastoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar tumour
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
subjects affected / exposed
|
10 / 2347 (0.43%) |
4 / 2348 (0.17%) |
7 / 2345 (0.30%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer recurrent
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extranodal marginal zone B-cell lymphoma (MALT type)
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric adenoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glioma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemangioma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary cancer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hodgkin's disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypopharyngeal cancer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lip neoplasm malignant stage unspecified
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
subjects affected / exposed
|
9 / 2347 (0.38%) |
9 / 2348 (0.38%) |
12 / 2345 (0.51%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm of auricular cartilage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm of renal pelvis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant palate neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinum neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone marrow
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
7 / 2348 (0.30%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to pleura
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to spine
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic pain
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myeloproliferative disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngeal cancer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage IV
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
2 / 2348 (0.09%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma metastatic
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma stage IV
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Penile cancer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pineal parenchymal neoplasm malignant
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural mesothelioma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
7 / 2348 (0.30%) |
19 / 2345 (0.81%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 8 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectosigmoid cancer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland adenoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer recurrent
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour flare
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour pain
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Accelerated hypertension
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aneurysm ruptured
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
8 / 2348 (0.34%) |
8 / 2345 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dilatation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic rupture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteritis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bleeding varicose vein
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
2 / 7 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
5 / 2348 (0.21%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic vascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Embolism arterial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery embolism
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery occlusion
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
1 / 2348 (0.04%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemodynamic instability
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
17 / 2347 (0.72%) |
13 / 2348 (0.55%) |
10 / 2345 (0.43%) |
occurrences causally related to treatment / all
|
0 / 19 |
1 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
subjects affected / exposed
|
37 / 2347 (1.58%) |
49 / 2348 (2.09%) |
26 / 2345 (1.11%) |
occurrences causally related to treatment / all
|
9 / 38 |
18 / 52 |
9 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iliac artery embolism
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iliac artery occlusion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
5 / 2348 (0.21%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic limb pain
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
3 / 2348 (0.13%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 3 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
18 / 2347 (0.77%) |
13 / 2348 (0.55%) |
11 / 2345 (0.47%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 15 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
8 / 2348 (0.34%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
4 / 2348 (0.17%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post thrombotic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Secondary hypertension
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicophlebitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular rupture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
Heart transplant
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implantable defibrillator insertion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Abasia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Accidental death
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
subjects affected / exposed
|
8 / 2347 (0.34%) |
5 / 2348 (0.21%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain death
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac complication associated with device
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
|
subjects affected / exposed
|
51 / 2347 (2.17%) |
68 / 2348 (2.90%) |
87 / 2345 (3.71%) |
occurrences causally related to treatment / all
|
0 / 51 |
1 / 68 |
1 / 87 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
subjects affected / exposed
|
75 / 2347 (3.20%) |
84 / 2348 (3.58%) |
82 / 2345 (3.50%) |
occurrences causally related to treatment / all
|
1 / 75 |
0 / 84 |
0 / 82 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device battery issue
|
|
|
|
subjects affected / exposed
|
13 / 2347 (0.55%) |
9 / 2348 (0.38%) |
14 / 2345 (0.60%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 9 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device breakage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device defective
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device electrical impedance issue
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device end of service
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device failure
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device inappropriate shock delivery
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device issue
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device lead damage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device lead issue
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
10 / 2348 (0.43%) |
9 / 2345 (0.38%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device signal detection issue
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device stimulation issue
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disease progression
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug withdrawal syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Exercise tolerance decreased
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Feeling abnormal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
3 / 2348 (0.13%) |
7 / 2345 (0.30%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hernia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ill-defined disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site erosion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site necrosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site pain
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inflammation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury associated with device
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lead dislodgement
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Localised oedema
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
4 / 2348 (0.17%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical device complication
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical device site thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metaplasia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multi-organ failure
|
|
|
|
subjects affected / exposed
|
21 / 2347 (0.89%) |
15 / 2348 (0.64%) |
12 / 2345 (0.51%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 15 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Necrosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
subjects affected / exposed
|
13 / 2347 (0.55%) |
15 / 2348 (0.64%) |
22 / 2345 (0.94%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 16 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
subjects affected / exposed
|
9 / 2347 (0.38%) |
6 / 2348 (0.26%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 7 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Organ failure
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
8 / 2348 (0.34%) |
7 / 2345 (0.30%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stent-graft endoleak
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
|
subjects affected / exposed
|
38 / 2347 (1.62%) |
39 / 2348 (1.66%) |
50 / 2345 (2.13%) |
occurrences causally related to treatment / all
|
2 / 38 |
5 / 39 |
3 / 50 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden death
|
|
|
|
subjects affected / exposed
|
98 / 2347 (4.18%) |
89 / 2348 (3.79%) |
86 / 2345 (3.67%) |
occurrences causally related to treatment / all
|
0 / 98 |
0 / 89 |
1 / 86 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Undersensing
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stent restenosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stent thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Allergy to venom
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart transplant rejection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transplant rejection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
|
Immobile
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Treatment noncompliance
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Acquired hydrocele
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
9 / 2348 (0.38%) |
7 / 2345 (0.30%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast hyperplasia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mammary fistula
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectocele
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal oedema
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spermatocele
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Acute pulmonary oedema
|
|
|
|
subjects affected / exposed
|
20 / 2347 (0.85%) |
20 / 2348 (0.85%) |
17 / 2345 (0.72%) |
occurrences causally related to treatment / all
|
0 / 24 |
2 / 25 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
subjects affected / exposed
|
13 / 2347 (0.55%) |
8 / 2348 (0.34%) |
14 / 2345 (0.60%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 12 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alveolitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Apnoea
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asphyxia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
8 / 2348 (0.34%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthmatic crisis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
8 / 2345 (0.34%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopleural fistula
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cheyne-Stokes respiration
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
32 / 2347 (1.36%) |
32 / 2348 (1.36%) |
43 / 2345 (1.83%) |
occurrences causally related to treatment / all
|
0 / 42 |
1 / 41 |
0 / 60 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic respiratory failure
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diaphragmatic paralysis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
54 / 2347 (2.30%) |
46 / 2348 (1.96%) |
35 / 2345 (1.49%) |
occurrences causally related to treatment / all
|
0 / 65 |
0 / 59 |
0 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea at rest
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea paroxysmal nocturnal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Emphysema
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
3 / 2348 (0.13%) |
8 / 2345 (0.34%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
2 / 2348 (0.09%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiccups
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercapnia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperventilation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung infiltration
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinal mass
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal pain
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthopnoea
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal oedema
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
10 / 2347 (0.43%) |
11 / 2348 (0.47%) |
12 / 2345 (0.51%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 13 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleurocutaneous fistula
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumomediastinum
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
6 / 2348 (0.26%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Productive cough
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary alveolar haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary artery thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
17 / 2347 (0.72%) |
18 / 2348 (0.77%) |
9 / 2345 (0.38%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 18 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
4 / 2348 (0.17%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
subjects affected / exposed
|
27 / 2347 (1.15%) |
27 / 2348 (1.15%) |
14 / 2345 (0.60%) |
occurrences causally related to treatment / all
|
0 / 37 |
0 / 30 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary venous thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
subjects affected / exposed
|
16 / 2347 (0.68%) |
16 / 2348 (0.68%) |
26 / 2345 (1.11%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 16 |
2 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Snoring
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suffocation feeling
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord leukoplakia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Abulia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute psychosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adjustment disorder
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcoholism
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anxiety
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anxiety disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Apathy
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Catatonia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Confusional state
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
6 / 2348 (0.26%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disorientation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fear
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Insomnia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mood disorder due to a general medical condition
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Restlessness
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Schizophrenia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Somatisation disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Acute hepatic failure
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
3 / 2348 (0.13%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary cirrhosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary dilatation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
5 / 2348 (0.21%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
4 / 2348 (0.17%) |
8 / 2345 (0.34%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
subjects affected / exposed
|
9 / 2347 (0.38%) |
9 / 2348 (0.38%) |
9 / 2345 (0.38%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
18 / 2347 (0.77%) |
15 / 2348 (0.64%) |
13 / 2345 (0.55%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 15 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic hepatitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic congestion
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis alcoholic
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatomegaly
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatorenal failure
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatotoxicity
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice hepatocellular
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-alcoholic steatohepatitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Portal hypertension
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
Anticoagulation drug level below therapeutic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anticoagulation drug level increased
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
4 / 2348 (0.17%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood ethanol increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood magnesium decreased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood potassium decreased
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood potassium increased
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood urine
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood urine present
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain natriuretic peptide increased
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac murmur
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac output decreased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardioactive drug level increased
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest X-ray abnormal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coagulation test abnormal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coagulation time prolonged
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ejection fraction abnormal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram QRS complex prolonged
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterobacter test positive
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gamma-glutamyltransferase increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate decreased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
International normalised ratio abnormal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
3 / 2348 (0.13%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lipase increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urine output decreased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral load increased
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
White blood cell count increased
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Accident
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Accidental exposure to product
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic complication
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
4 / 2348 (0.17%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Burns third degree
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carbon monoxide poisoning
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac function disturbance postoperative
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac procedure complication
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery restenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest injury
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Closed globe injury
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complications of transplanted heart
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery reocclusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary vascular graft occlusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Excoriation
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
subjects affected / exposed
|
9 / 2347 (0.38%) |
8 / 2348 (0.34%) |
11 / 2345 (0.47%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
subjects affected / exposed
|
9 / 2347 (0.38%) |
10 / 2348 (0.43%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 11 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foreign body
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fractured ischium
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stoma complication
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
5 / 2348 (0.21%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incision site haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal anastomosis complication
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ligament injury
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Limb injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lip injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mouth injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle injury
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
9 / 2348 (0.38%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 9 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery restenosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Poisoning
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural bile leak
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post-traumatic pain
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative hernia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative thoracic procedure complication
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Product name confusion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
5 / 2348 (0.21%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory fume inhalation disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
subjects affected / exposed
|
8 / 2347 (0.34%) |
6 / 2348 (0.26%) |
8 / 2345 (0.34%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sacroiliac fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shunt stenosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin abrasion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Soft tissue injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
5 / 2348 (0.21%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transplant failure
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic liver injury
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic shock
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Underdose
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stricture traumatic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular bypass dysfunction
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vasoplegia syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
Atrial septal defect
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermoid cyst
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
18 / 2348 (0.77%) |
16 / 2345 (0.68%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 19 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
5 / 2348 (0.21%) |
9 / 2345 (0.38%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
subjects affected / exposed
|
49 / 2347 (2.09%) |
40 / 2348 (1.70%) |
46 / 2345 (1.96%) |
occurrences causally related to treatment / all
|
0 / 50 |
1 / 41 |
1 / 47 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adams-Stokes syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
35 / 2347 (1.49%) |
33 / 2348 (1.41%) |
37 / 2345 (1.58%) |
occurrences causally related to treatment / all
|
0 / 41 |
1 / 39 |
1 / 51 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
subjects affected / exposed
|
47 / 2347 (2.00%) |
48 / 2348 (2.04%) |
41 / 2345 (1.75%) |
occurrences causally related to treatment / all
|
0 / 68 |
0 / 54 |
0 / 49 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
subjects affected / exposed
|
13 / 2347 (0.55%) |
15 / 2348 (0.64%) |
12 / 2345 (0.51%) |
occurrences causally related to treatment / all
|
1 / 13 |
0 / 17 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia supraventricular
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
89 / 2347 (3.79%) |
98 / 2348 (4.17%) |
97 / 2345 (4.14%) |
occurrences causally related to treatment / all
|
0 / 105 |
1 / 120 |
0 / 118 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
subjects affected / exposed
|
15 / 2347 (0.64%) |
21 / 2348 (0.89%) |
11 / 2345 (0.47%) |
occurrences causally related to treatment / all
|
1 / 17 |
0 / 25 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
8 / 2348 (0.34%) |
13 / 2345 (0.55%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 8 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
4 / 2348 (0.17%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bifascicular block
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
12 / 2347 (0.51%) |
12 / 2348 (0.51%) |
9 / 2345 (0.38%) |
occurrences causally related to treatment / all
|
0 / 12 |
2 / 13 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bundle branch block
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
subjects affected / exposed
|
59 / 2347 (2.51%) |
61 / 2348 (2.60%) |
59 / 2345 (2.52%) |
occurrences causally related to treatment / all
|
0 / 63 |
0 / 63 |
3 / 62 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac asthma
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
4 / 2348 (0.17%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac discomfort
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
3 / 2348 (0.13%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
|
subjects affected / exposed
|
480 / 2347 (20.45%) |
521 / 2348 (22.19%) |
503 / 2345 (21.45%) |
occurrences causally related to treatment / all
|
15 / 892 |
17 / 996 |
20 / 903 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
|
subjects affected / exposed
|
54 / 2347 (2.30%) |
43 / 2348 (1.83%) |
60 / 2345 (2.56%) |
occurrences causally related to treatment / all
|
1 / 75 |
1 / 56 |
2 / 80 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
|
subjects affected / exposed
|
120 / 2347 (5.11%) |
125 / 2348 (5.32%) |
122 / 2345 (5.20%) |
occurrences causally related to treatment / all
|
3 / 209 |
3 / 189 |
8 / 220 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
subjects affected / exposed
|
76 / 2347 (3.24%) |
85 / 2348 (3.62%) |
79 / 2345 (3.37%) |
occurrences causally related to treatment / all
|
3 / 123 |
4 / 136 |
1 / 140 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac flutter
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac hypertrophy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac perforation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac sarcoidosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
subjects affected / exposed
|
24 / 2347 (1.02%) |
24 / 2348 (1.02%) |
20 / 2345 (0.85%) |
occurrences causally related to treatment / all
|
1 / 24 |
3 / 24 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
|
subjects affected / exposed
|
31 / 2347 (1.32%) |
49 / 2348 (2.09%) |
38 / 2345 (1.62%) |
occurrences causally related to treatment / all
|
1 / 32 |
2 / 52 |
0 / 44 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomegaly
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
6 / 2348 (0.26%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiorenal syndrome
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chordae tendinae rupture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronotropic incompetence
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
subjects affected / exposed
|
14 / 2347 (0.60%) |
14 / 2348 (0.60%) |
19 / 2345 (0.81%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 14 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
subjects affected / exposed
|
28 / 2347 (1.19%) |
27 / 2348 (1.15%) |
22 / 2345 (0.94%) |
occurrences causally related to treatment / all
|
0 / 31 |
1 / 29 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
subjects affected / exposed
|
8 / 2347 (0.34%) |
5 / 2348 (0.21%) |
8 / 2345 (0.34%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
|
subjects affected / exposed
|
13 / 2347 (0.55%) |
7 / 2348 (0.30%) |
13 / 2345 (0.55%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 8 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
6 / 2348 (0.26%) |
8 / 2345 (0.34%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
5 / 2348 (0.21%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
17 / 2348 (0.72%) |
14 / 2345 (0.60%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 19 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve prolapse
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
subjects affected / exposed
|
56 / 2347 (2.39%) |
50 / 2348 (2.13%) |
50 / 2345 (2.13%) |
occurrences causally related to treatment / all
|
1 / 63 |
0 / 51 |
0 / 57 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
19 / 2347 (0.81%) |
19 / 2348 (0.81%) |
18 / 2345 (0.77%) |
occurrences causally related to treatment / all
|
0 / 20 |
1 / 19 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nodal rhythm
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Papillary muscle rupture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary valve incompetence
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Restrictive cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rhythm idioventricular
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus arrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
3 / 2348 (0.13%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachyarrhythmia
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
5 / 2348 (0.21%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Systolic dysfunction
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
subjects affected / exposed
|
9 / 2347 (0.38%) |
5 / 2348 (0.21%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia paroxysmal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tricuspid valve disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
|
subjects affected / exposed
|
14 / 2347 (0.60%) |
8 / 2348 (0.34%) |
14 / 2345 (0.60%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 8 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular dyssynchrony
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
subjects affected / exposed
|
8 / 2347 (0.34%) |
9 / 2348 (0.38%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular failure
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
|
subjects affected / exposed
|
32 / 2347 (1.36%) |
30 / 2348 (1.28%) |
34 / 2345 (1.45%) |
occurrences causally related to treatment / all
|
2 / 33 |
2 / 33 |
1 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular flutter
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachyarrhythmia
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
subjects affected / exposed
|
78 / 2347 (3.32%) |
67 / 2348 (2.85%) |
63 / 2345 (2.69%) |
occurrences causally related to treatment / all
|
2 / 97 |
2 / 92 |
0 / 75 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
Ageusia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Altered state of consciousness
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Amyotrophic lateral sclerosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aphasia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atonic seizures
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basilar artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain hypoxia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain injury
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem infarction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
5 / 2348 (0.21%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar ataxia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral amyloid angiopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral artery embolism
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral artery occlusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral atrophy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
9 / 2348 (0.38%) |
7 / 2345 (0.30%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
subjects affected / exposed
|
9 / 2347 (0.38%) |
17 / 2348 (0.72%) |
17 / 2345 (0.72%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 17 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
subjects affected / exposed
|
44 / 2347 (1.87%) |
51 / 2348 (2.17%) |
62 / 2345 (2.64%) |
occurrences causally related to treatment / all
|
1 / 48 |
0 / 53 |
2 / 69 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervicogenic headache
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complex partial seizures
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dementia
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic coma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic hyperosmolar coma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
subjects affected / exposed
|
11 / 2347 (0.47%) |
9 / 2348 (0.38%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 10 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyslalia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Embolic cerebral infarction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalomalacia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
7 / 2348 (0.30%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
4 / 2348 (0.17%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hemianopia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hemianopia homonymous
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic seizure
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
IIIrd nerve paresis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraventricular haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
subjects affected / exposed
|
45 / 2347 (1.92%) |
45 / 2348 (1.92%) |
29 / 2345 (1.24%) |
occurrences causally related to treatment / all
|
1 / 47 |
0 / 51 |
0 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lacunar infarction
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukoencephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
3 / 2348 (0.13%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental retardation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Monoparesis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Monoplegia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Motor neurone disease
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Narcolepsy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic intolerance
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paresis cranial nerve
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral sensory neuropathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postresuscitation encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
5 / 2348 (0.21%) |
9 / 2345 (0.38%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 5 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychomotor hyperactivity
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Restless legs syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retrograde amnesia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reversible ischaemic neurological deficit
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Somnolence
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal claudication
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal epidural haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
subjects affected / exposed
|
48 / 2347 (2.05%) |
56 / 2348 (2.39%) |
27 / 2345 (1.15%) |
occurrences causally related to treatment / all
|
5 / 58 |
7 / 71 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tension headache
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thalamus haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
23 / 2347 (0.98%) |
20 / 2348 (0.85%) |
15 / 2345 (0.64%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 20 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tremor
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Trigeminal nerve disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uraemic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VIIth nerve paralysis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Acquired haemophilia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia
|
|
|
|
subjects affected / exposed
|
36 / 2347 (1.53%) |
28 / 2348 (1.19%) |
28 / 2345 (1.19%) |
occurrences causally related to treatment / all
|
2 / 39 |
0 / 40 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia vitamin B12 deficiency
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aplastic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bicytopenia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone marrow infiltration
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemolytic anaemia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic diathesis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypocoagulable state
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice acholuric
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy mediastinal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polycythaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal lymphadenopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Splenic embolism
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Splenic vein thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
Deafness neurosensory
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Deafness unilateral
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematotympanum
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meniere's disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tympanic membrane perforation
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Amaurosis fugax
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Amblyopia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
subjects affected / exposed
|
13 / 2347 (0.55%) |
8 / 2348 (0.34%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Conjunctival haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Macular hole
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ocular fistula
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ocular retrobulbar haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ophthalmic vein thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal artery embolism
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal degeneration
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal vein occlusion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Abdominal adhesions
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal discomfort
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
subjects affected / exposed
|
14 / 2347 (0.60%) |
10 / 2348 (0.43%) |
11 / 2345 (0.47%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 23 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
5 / 2348 (0.21%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal strangulated hernia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acid peptic disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcoholic pancreatitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal prolapse
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
6 / 2348 (0.26%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune pancreatitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
5 / 2348 (0.21%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dental caries
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
18 / 2347 (0.77%) |
4 / 2348 (0.17%) |
11 / 2345 (0.47%) |
occurrences causally related to treatment / all
|
1 / 20 |
0 / 4 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dieulafoy's vascular malformation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eosinophilic oesophagitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epigastric discomfort
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral hernia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral hernia, obstructive
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
4 / 2348 (0.17%) |
8 / 2345 (0.34%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
2 / 2348 (0.09%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
subjects affected / exposed
|
10 / 2347 (0.43%) |
4 / 2348 (0.17%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroduodenal ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
19 / 2347 (0.81%) |
13 / 2348 (0.55%) |
11 / 2345 (0.47%) |
occurrences causally related to treatment / all
|
0 / 19 |
1 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal inflammation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal polyp haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gingival bleeding
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
5 / 2348 (0.21%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
subjects affected / exposed
|
23 / 2347 (0.98%) |
21 / 2348 (0.89%) |
14 / 2345 (0.60%) |
occurrences causally related to treatment / all
|
1 / 23 |
0 / 21 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal fistula
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal strangulation
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
5 / 2348 (0.21%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
4 / 2348 (0.17%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mesenteric artery embolism
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mesenteric artery thrombosis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mesenteritis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mouth haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Obstruction gastric
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedematous pancreatitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic cyst
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
4 / 2348 (0.17%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
subjects affected / exposed
|
9 / 2347 (0.38%) |
5 / 2348 (0.21%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngo-oesophageal diverticulum
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Portal hypertensive gastropathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proctalgia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proctitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
5 / 2348 (0.21%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stress ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subileus
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis mesenteric vessel
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tongue oedema
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth disorder
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
5 / 2348 (0.21%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
12 / 2348 (0.51%) |
7 / 2345 (0.30%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 12 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Visceral congestion
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Volvulus
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Volvulus of small bowel
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
5 / 2348 (0.21%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Acquired epidermolysis bullosa
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Actinic keratosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angioedema
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis bullous
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis contact
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug eruption
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ecchymosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erythema
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fungating wound
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Henoch-Schonlein purpura
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intertrigo
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lichen sclerosus
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peau d'orange
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Precancerous skin lesion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pruritus
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Purpura
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seborrhoeic dermatitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
4 / 2348 (0.17%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxic skin eruption
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Acute kidney injury
|
|
|
|
subjects affected / exposed
|
52 / 2347 (2.22%) |
29 / 2348 (1.24%) |
38 / 2345 (1.62%) |
occurrences causally related to treatment / all
|
12 / 60 |
5 / 31 |
1 / 41 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute prerenal failure
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anuria
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urethral
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
subjects affected / exposed
|
21 / 2347 (0.89%) |
10 / 2348 (0.43%) |
10 / 2345 (0.43%) |
occurrences causally related to treatment / all
|
6 / 24 |
0 / 10 |
3 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glomerulonephritis membranous
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
6 / 2348 (0.26%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic nephropathy
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephritis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyuria
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postrenal failure
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal embolism
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
subjects affected / exposed
|
33 / 2347 (1.41%) |
26 / 2348 (1.11%) |
27 / 2345 (1.15%) |
occurrences causally related to treatment / all
|
6 / 34 |
4 / 26 |
4 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
subjects affected / exposed
|
34 / 2347 (1.45%) |
31 / 2348 (1.32%) |
33 / 2345 (1.41%) |
occurrences causally related to treatment / all
|
9 / 36 |
8 / 33 |
8 / 33 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric fistula
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
7 / 2348 (0.30%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinoma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Goitre
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
5 / 2348 (0.21%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
7 / 2348 (0.30%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyrotoxic crisis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxic nodular goitre
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Arthralgia
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
3 / 2348 (0.13%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chondropathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Connective tissue inflammation
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic amyotrophy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fistula
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Flank pain
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fracture malunion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint instability
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle atrophy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
5 / 2348 (0.21%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal stiffness
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myopathy
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myopathy toxic
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myositis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
9 / 2347 (0.38%) |
12 / 2348 (0.51%) |
10 / 2345 (0.43%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 15 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteochondritis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis of jaw
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
3 / 2348 (0.13%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatic disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
4 / 2348 (0.17%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scleroderma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal deformity
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Abdominal abscess
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal sepsis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess intestinal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess oral
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acinetobacter infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
2 / 2348 (0.09%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial diarrhoea
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
22 / 2347 (0.94%) |
16 / 2348 (0.68%) |
11 / 2345 (0.47%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 16 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis viral
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Burn infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac valve abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
9 / 2348 (0.38%) |
13 / 2345 (0.55%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridial infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Corynebacterium infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
6 / 2348 (0.26%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
0 / 2348 (0.00%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysentery
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Empyema
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
5 / 2348 (0.21%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis staphylococcal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
7 / 2348 (0.30%) |
10 / 2345 (0.43%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fungal oesophagitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
subjects affected / exposed
|
10 / 2347 (0.43%) |
3 / 2348 (0.13%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer helicobacter
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
13 / 2347 (0.55%) |
10 / 2348 (0.43%) |
16 / 2345 (0.68%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 10 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Genitourinary tract infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemophilus sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic infection bacterial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis viral
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster cutaneous disseminated
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Human ehrlichiosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incision site abscess
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incision site infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected cyst
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
2 / 2348 (0.09%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
4 / 2348 (0.17%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Localised infection
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
4 / 2348 (0.17%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
6 / 2348 (0.26%) |
9 / 2345 (0.38%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung infection
|
|
|
|
subjects affected / exposed
|
10 / 2347 (0.43%) |
6 / 2348 (0.26%) |
13 / 2345 (0.55%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 9 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lyme disease
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mucormycosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mycobacterial infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myiasis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral fungal infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orchitis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngitis fungal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Otitis media acute
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Otitis media chronic
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parametritis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paronychia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
3 / 2348 (0.13%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
5 / 2348 (0.21%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumocystis jirovecii infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
136 / 2347 (5.79%) |
145 / 2348 (6.18%) |
122 / 2345 (5.20%) |
occurrences causally related to treatment / all
|
1 / 164 |
0 / 176 |
0 / 146 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia escherichia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia haemophilus
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia mycoplasmal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pseudomonal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomonal sepsis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomonas infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psoas abscess
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
|
subjects affected / exposed
|
8 / 2347 (0.34%) |
6 / 2348 (0.26%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
3 / 2348 (0.13%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
subjects affected / exposed
|
8 / 2347 (0.34%) |
15 / 2348 (0.64%) |
19 / 2345 (0.81%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 19 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection bacterial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection fungal
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection viral
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
14 / 2347 (0.60%) |
18 / 2348 (0.77%) |
12 / 2345 (0.51%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 19 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic necrosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
subjects affected / exposed
|
13 / 2347 (0.55%) |
21 / 2348 (0.89%) |
13 / 2345 (0.55%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 21 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sialoadenitis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin bacterial infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin infection
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal endocarditis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis septic
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tracheitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
5 / 2348 (0.21%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
4 / 2347 (0.17%) |
5 / 2348 (0.21%) |
6 / 2345 (0.26%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection bacterial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethritis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
22 / 2347 (0.94%) |
21 / 2348 (0.89%) |
19 / 2345 (0.81%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 22 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection pseudomonal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
7 / 2348 (0.30%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
3 / 2348 (0.13%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral pericarditis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral vasculitis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection bacterial
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection staphylococcal
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound sepsis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Acidosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cachexia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carbohydrate intolerance
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
6 / 2348 (0.26%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 9 |
2 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
subjects affected / exposed
|
27 / 2347 (1.15%) |
21 / 2348 (0.89%) |
14 / 2345 (0.60%) |
occurrences causally related to treatment / all
|
1 / 30 |
0 / 24 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
subjects affected / exposed
|
15 / 2347 (0.64%) |
16 / 2348 (0.68%) |
10 / 2345 (0.43%) |
occurrences causally related to treatment / all
|
1 / 16 |
0 / 16 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
|
subjects affected / exposed
|
7 / 2347 (0.30%) |
6 / 2348 (0.26%) |
4 / 2345 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
|
subjects affected / exposed
|
3 / 2347 (0.13%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glucose tolerance impaired
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
subjects affected / exposed
|
11 / 2347 (0.47%) |
11 / 2348 (0.47%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 14 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
6 / 2347 (0.26%) |
1 / 2348 (0.04%) |
3 / 2345 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
21 / 2347 (0.89%) |
13 / 2348 (0.55%) |
20 / 2345 (0.85%) |
occurrences causally related to treatment / all
|
12 / 22 |
6 / 14 |
11 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperosmolar hyperglycaemic state
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperosmolar state
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertriglyceridaemia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperuricaemia
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
10 / 2347 (0.43%) |
5 / 2348 (0.21%) |
5 / 2345 (0.21%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
10 / 2347 (0.43%) |
12 / 2348 (0.51%) |
10 / 2345 (0.43%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 14 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
5 / 2347 (0.21%) |
7 / 2348 (0.30%) |
10 / 2345 (0.43%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypophagia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoproteinaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
2 / 2348 (0.09%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Insulin resistance
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
1 / 2348 (0.04%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Marasmus
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
|
subjects affected / exposed
|
2 / 2347 (0.09%) |
0 / 2348 (0.00%) |
2 / 2345 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic disorder
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mineral deficiency
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Obesity
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
0 / 2348 (0.00%) |
0 / 2345 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polydipsia
|
|
|
|
subjects affected / exposed
|
0 / 2347 (0.00%) |
0 / 2348 (0.00%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
|
subjects affected / exposed
|
1 / 2347 (0.04%) |
1 / 2348 (0.04%) |
1 / 2345 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
|
subjects affected / exposed
|
12 / 2347 (0.51%) |
10 / 2348 (0.43%) |
8 / 2345 (0.34%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |